PARIS--(BUSINESS WIRE)--Regulatory News:
Pixium Vision (Paris:PIX), a company developing innovative bionic vision systems with the intention to allow patients who have lost their sight to lead more independent lives, today announced that the German Institute for the Hospital Remuneration System (InEK) has granted NUB (Neue Untersuchungs- und Behandlungsmethoden) Status-1 for IRIS®II, Pixium Vision’s first bionic vision system, equipped with a bio-inspired camera and a 150 electrodes epi-retinal implant with a proprietary design intended to be explantable and upgradable.
The NUB process allows negotiations between hospitals and statutory health insurances on the potential reimbursement of new medical treatments in the German statutory health insurance system (detailed information on the NUB process and Status is available at http://www.g-drg.de/G-DRG-System_2017/Neue_Untersuchungs-_und_Behandlungsmethoden_NUB). Based on NUB Status-1 for IRIS® II, ophthalmic hospitals can negotiate reimbursement coverage under the German statutory health insurance system for IRIS®II treatment for patients with advanced outer retinal degeneration due to Retinitis Pigmentosa (RP). A NUB decision is valid for one year and can be renewed annually.
Khalid Ishaque, Chief Executive Officer of Pixium Vision said: “After having received the CE mark for IRIS®II, obtaining market access and reimbursement has been the main focus as we continue on our mission towards innovative treatment options. We intend to progressively expand availability across Germany as well as other regions. Obtaining the NUB Status-1 supports our ongoing efforts to bring innovations in bionic vision capabilities to patients blinded by retinal dystrophies.”
The clinical centers offering IRIS®II initially include ophthalmic hospitals at the following university clinics:
- Universitätsklinikum Aachen
- Universitätsklinikum Bonn
- Universitätsklinikum Freiburg
- Universitätsklinikum Hamburg-Eppendorf
- Klinikum der Universität München
ABOUT IRIS®II
IRIS®II is a bionic vision system equipped with a bio-inspired camera and a 150 electrodes epi-retinal implant with a proprietary design intended to be explantable and eventually upgradable for patients who have lost sight due to Retinitis Pigmentosa (RP).
The Company received CE mark for IRIS®II in 2016, enabling Pixium to launch its commercial activities subject to reimbursement availabilities. CE mark approval for IRIS®II system enables the company to file for national reimbursements. The Company is working initially with public reimbursement authorities for innovative technologies for medical devices in France (under “Forfait Innovation”) and in Germany (with NUB).
ABOUT PIXIUM VISION
Pixium Vision’s mission is to create a world of bionic vision for those who have lost their sight, enabling them to regain partial visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention as well as a rehabilitation period.
The company is developing two bionic retinal implant systems. IRIS®II, the company first bionic system, obtained CE mark in July 2016. In parallel, Pixium Vision has recently completed the pre-clinical study phases for PRIMA, a sub-retinal miniaturized wireless photovoltaic implant platform, and is planning to initiate first-in-human trials.
Pixium Vision collaborates closely with academic and research partners spanning across prestigious vision research institutions including the Institut de la Vision in Paris, the Hansen Experimental Physics Laboratory at Stanford University, and Moorfields Eye Hospital in London. The company is EN ISO 13485 certified.
For more information, please visit: www.pixium-vision.com;
Pixium Vision is listed on Euronext Paris (Compartment C). Pixium Vision shares are eligible for the French tax incentivized PEA-PME and FCPI investment vehicles.
Euronext ticker: PIX - ISIN: FR0011950641 – Reuters: PIX.PA – Bloomberg: PIX:FP
Disclaimer:
This press release may expressly or implicitly contain forward-looking statements relating to Pixium Vision and its activity. Such statements are related to known or unknown risks, uncertainties and other factors that could lead actual results, financial conditions, performance or achievements to differ materially from Vision Pixium results, financial conditions, performance or achievements expressed or implied by such forward looking statements.
Pixium Vision provides this press release as of the aforementioned date and does not commit to update forward looking statements contained herein, whether as a result of new information, future events or otherwise.
For a description of risks and uncertainties which could lead to discrepancies between actual results, financial condition, performance or achievements and those contained in the forward-looking statements, please refer to Chapter 4 "Risk Factors" of the company’s Registration Document filed with the AMF under number R16-033 on April 28, 2016 which can be found on the websites of the AMF - AMF (www.amf-france.org) and of Pixium Vision (www.pixium-vision.com).
IRIS® is a trademark of Pixium-Vision SA
